Probiotic in Infant Growth, Allergy and Immunity Study

Prospective, Placebo-Controlled, Randomized Double-Blind Clinical Study on the Intervention of Animal-Derived Probiotic in Infant Growth and Development, Allergy Incidence, and Immune Function

To evaluate the intervention effects of Bifidobacterium animalis subsp. lactis strain BLa80 in promoting growth and development (including gut microbiota and physical growth and development) of healthy infants and young children across different age groups, enhancing immune function, improving allergy incidence, and analyzing the safety of BLa80 in relation to infant growth and development, allergy incidence, and gut microbiota.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy; Infant ALL
• Intervention / Treatment: Dietary supplement: Probiotic BLa80; Other: Placebo Maltodextrin

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vicky Achmad Ginanjar, bachelor; Phone Number: +62 +62 21 7695513, 7515932; Email: vicky.achmad@equilab-int.com
• Study Contact Backup: Name: Natalina Soesilawati, Dr.; Phone Number: +62 21 88324366

Study Locations

• Indonesia
  • Jakarta 10430
    • Jakarta Pusat, Jakarta 10430, Indonesia, 10430
      • Fakultas Kedokteran Universitas Indonesia
      • Contact: Natalina Soesilawati; Phone Number: +62 +62 21 7695513, 7515932; Email: ec_fkui@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy infants and young children born at 37 to 42 weeks of gestation through both artificial breastfeeding, with a birth weight greater than or equal to 2500 g and less than 4000 g, regardless of gender
2. Infants and young children whose mothers do not have diagnosed metabolic disorders such as diabetes and are not afflicted with communicable diseases such as hepatitis B or HIV
3. Enrollment will be stratified into three age groups: 0-6 months, 6-12 months, and 12-36 months
4. Consent from parents or primary caregivers of infants and young children to collect faecal samples during the study
5. No clinically diagnosed allergic diseases at the time of enrolment (including but not limited to eczema, asthma, allergic colitis, allergic rhinitis, pollen allergies, etc.)
6. Infants and young children with a medical record established at local maternal and child health care hospital's paediatrics department, undergoing regular check-ups, and following feeding advice and guidance from pediatricians
7. Assurance from family members or primary caregivers not to administer additional probiotic products (including formula milk containing probiotics) to infants and young children during the intervention period.

Exclusion Criteria:

• Healthy infants and young children aged 0-6 months:

  1. Infants with a history of asphyxia at birth or a history of NICU hospitalization
  2. Infants born with congenital defects or abnormalities
  3. Infants whose mother had pregnancy-related conditions such as gestational hypertension, pre-eclampsia or eclampsia, gestational diabetes, cholestasis of pregnancy, or other high-risk obstetric factors, as well as a history of alcohol or drug abuse during pregnancy
  4. Infants who have used antibiotics within 2 weeks prior to enrollment
  5. Infants who have had specific diseases affecting growth and development within 1 month prior to enrollment (e.g., pneumonia, severe diarrhea, severe constipation, severe cow's milk protein allergy, malnutrition, gastrointestinal surgery, severe congenital heart disease, epilepsy, cerebral palsy, developmental delay, confirmed genetic metabolic disorders, chromosomal disorders, genetic diseases, etc.)
  6. Infants with severe primary diseases affecting other important organs or systems such as the heart, liver, kidney, hematopoietic system, etc.
  7. Infants who have used investigational drugs or participated in other clinical studies before screening
  8. Infants who have consumed probiotic products within 1 month prior to enrollment (calculated from birth to enrollment for infants aged <1 month)
  9. Infants who have used immunosuppressive drugs (such as glucocorticoids, immunosuppressants) before enrollment
  10. Infants with known allergies to the ingredients of probiotic products
  11. Children who require hospitalization for treatment due to malnutrition
  12. Other reasons that researchers consider as unsuitable for participation in the clinical trial, such as those that could affect efficacy evaluation or individuals with poor compliance

Infants and young children aged 6-12 months with good health

1. Infants who have used antibiotics within 2 weeks prior to enrollment
2. Infants who have had specific diseases affecting growth and development within the 1 month prior to enrollment (Infants who have had specific diseases affecting growth and development within 1 month prior to enrollment (e.g., pneumonia, severe diarrhea, severe constipation, severe cow's milk protein allergy, malnutrition, gastrointestinal surgery, severe congenital heart disease, epilepsy, cerebral palsy, developmental delay, confirmed genetic metabolic disorders, chromosomal disorders, genetic diseases, etc.)
3. Infants with severe primary diseases affecting other important organs or systems such as the heart, liver, kidney, hematopoietic system, etc.
4. Infants who have used investigational drugs or participated in other clinical studies within 3 months prior to screening
5. Infants who have consumed probiotic products within 1 month prior to enrollment
6. Infants who have used immunosuppressive drugs (such as glucocorticoids, immunosuppressants) before enrollment
7. Infants with known allergies to the ingredients of probiotic products
8. Children who require hospitalization for treatment due to malnutrition
9. Other reasons that researchers consider as unsuitable for participation in the clinical trial, such as those that could affect efficacy evaluation or individuals with poor compliance

Infants and young children aged 12-36 months with good health

1. Infants who have used antibiotics within 2 weeks prior to enrollment
2. Infants who have had specific diseases affecting growth and development within the 1 month prior to enrollment, such as pneumonia, severe diarrhea, severe constipation, severe cow's milk protein allergy, malnutrition, gastrointestinal surgery, severe congenital heart disease, epilepsy, cerebral palsy, developmental delay, confirmed genetic metabolic disorders, chromosomal disorders, genetic diseases, etc.
3. Infants with severe primary diseases affecting other important organs or systems such as the heart, liver, kidney, hematopoietic system, etc.
4. Infants who have used investigational drugs or participated in other clinical studies within 3 months prior to screening
5. Infants who have consumed probiotic products within 1 month prior to enrollment
6. Infants who have used immunosuppressive drugs (such as glucocorticoids, immunosuppressants) before enrollment
7. Infants with known allergies to the ingredients of probiotic products
8. Children who require hospitalization for treatment due to malnutrition
9. Other reasons that researchers consider as unsuitable for participation in the clinical trial, such as those that could affect efficacy evaluation or individuals with poor compliance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic BLa80; Participants receive one sachet per day containing probiotic BLa80 and maltodextrin (Day 0 to Day 84).	Dietary supplement: Probiotic BLa80; Collect baby fecal samples, test for 16S rRNA, and analyze changes in the gut microbiota before and after supplementation.
Placebo Comparator: Maltodextrin; Participants receive one sachet per day containing maltodextrin only, serving as the placebo (Day 0 to Day 84).	Other: Placebo Maltodextrin; Collect baby fecal samples, test for 16S rRNA, and analyze changes in the gut microbiota before and after supplementation.
No Intervention: Blank; Participants in this arm will not receive any intervention or placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in gut microbiota	Collect patient fecal samples, test for 16S rRNA.	84 days

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.
• Investigators: Principal Investigator: Natalina Soesilawati, Dr., Karya Medika II Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2024
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): September 25, 2024

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: WK2024006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No